Council News July 2025

President's winter message

At the Pharmacy Council we believe engagement and communication about pharmacy regulation in NSW and the Council’s role is critical.

To help with this we’ve participated in a number of engagement sessions at the annual Pharmacy Connect Conference on regulatory matters over the past 2 years.

Owning a pharmacy in NSW is both a privilege and a responsibility which is also governed by strict regulatory requirements. Therefore, the process of buying or selling a pharmacy as well as the application for regulatory approval can be lengthy and complex.

I’m delighted to announce as part of our drive to engage with you on important and relevant topics, the Pharmacy Council will participate in an information session at this year’s Pharmacy Connect about the pharmacy ownership application process in NSW.

The Pharmacy Connect Conference is the premier Pharmacy Conference in NSW which is attended by pharmacy proprietors as well as potential future pharmacy owners. It will be held during September 3-5 in Sydney.

As the application process can be complex a practical information session has been developed by an expert in the field to demystify the application process for change or variation of ownerships. They will also highlight the critical role of the Pharmacy Council of NSW in approving new premises, changes in ownership structure and the registration of financial interests.

You’ll learn about the application submission process, time frames and what is required to make a completed application ready for expeditated Council approval.

The session will provide general information only and won’t provide legal advice, there also won’t be any discussions around current applications. For any legal questions you must seek your own individual legal advice. If you have any questions around current applications, please contact the Pharmacy Council directly.

The session - Demystifying Pharmacy approval applications in NSW - pre Conference workshop 5 will be held on Wednesday 3 September. Seats are limited and bookings are essential. The fees are set by the conference and go towards covering the costs associated with holding the session.

On behalf of the Pharmacy Council, I’d also like to thank the Pharmacy Connect organisers for their support.

I hope to see you at the conference!

Kind regards,

Rick Samimi

President, Pharmacy Council of NSW

Pharmacy ownership applications to the NSW register

One of the responsibilities of the Pharmacy Council of NSW (the Council) is maintaining the register of pharmacies in NSW. The register includes the details of approved premises for operating a pharmacy business by a pharmacist, as well as the financial interests of the registered holders of the business.

What are the legal responsibilities?

The Health Practitioner Regulation National Law (NSW) states that a person cannot have a pharmacy business unless the premises have current approval and all holders who have a financial interest are registered in the National Register of Pharmacists. A National Register is maintained by the Australian Health Practitioner Regulation Agency.

With limited exceptions, only a registered pharmacist, a partnership of registered pharmacists and a pharmacist's body corporate (as defined in the National Law (NSW)) can hold a financial interest in a pharmacy business in NSW.

The Council would like to stress that we take this aspect of the National Law very seriously and as part of our assessment we need to make sure that the financial interests provisions for ownership are met.

How does the Council assess applications?

Council currently receives about 30-40 notices and applications relating to the Register every month. The Council makes an independent assessment of each application to make sure they meet the terms of the National Law. We’re very conscious of the day-to-day pressures of pharmacy ownership and aim to balance expediency with ensuring compliance with the National Law.

Why do some applications take longer to process?

Although most applications are processed quickly once a complete and compliant application is received, those which involve trusts, complex financing and franchise or banner groups often require additional time to review.

Delays are also common when application submissions are incomplete. A recent audit of 50 applications found a staggering 98% were incomplete when submitted. This means Council needed to request further information, clarification or changes, resulting in much longer processing times while information is sought and provided.

What can I do to help with application processing times?

Some ways in which applicant owners can support timely processing includes ensuring:

your submission has the correct address across all supporting documents and it’s the same as the current registered premises
complete documentation is submitted, such as lease agreements (sublease, variation of lease, assignment of lease and importantly consent from the landlord)
all statutory declarations are correctly signed, dated and witnessed
supporting documents are correctly dated and properly executed (e.g. sale contracts, deeds of assignment, lease documentation).

Improving the management of ownership applications

The Council, with the support of the Health Professions Council Authority (HPCA), have made significant investments in infrastructure and resourcing over the past 18 months which has led to shorter processing times.

This includes a reduction of 60% in duration from date of submission to date approved. The current average duration is within 6 weeks. Approximately 40% of all applications are finalised within 30 calendar days. We acknowledge more can be done to improve processing times as well as our communication. We’re continuing to review our supporting technology, processes and resourcing to help with this.

Some delays are out of our control with the majority of applications submitted with incomplete or inaccurate information. When the documentation is correctly provided, the vast majority of applications are approved within 10 days. Currently significant time continues to be spent on incomplete applications and the need to request accurate or complete documentation. We are focussed on continuing to improve application turnaround times however, we can only assess complete and compliant applications.

What do I need to do if I’m going to submit an application soon?

We strongly encourage all Pharmacists considering an application to review all materials before submitting to ensure any new or altered arrangements, or agreements being entered are compliant with the legislation in NSW.

Please see our website which provides information regarding the financial interest provisions, along with guidance about what materials should be supplied with any application or notice. For matters which include complex ownership, trust or banner group arrangements these will take longer to process.

Advice in relation to internet and mail-order dispensing

The Council recommends pharmacists familiarise themselves with the Pharmacy Board of Australia Guidelines for dispensing of medicines. They focus on safe dispensing and labelling of medicines, including compounded (or extemporaneously prepared) medicines as well as on providing a good pharmacy service. The guidelines also address the role of dispensary assistants/technicians. Pharmacists who dispense compounded medicines should also refer to the Board’s Guidelines on compounding of medicines.

With respect to the indirect supply of medicines, patient circumstances and consumer preferences, please see Guideline 5 internet, mail-order dispensing and other indirect supply of medicines, within the Guidelines for dispensing of medicines.

Under section 41 of the National Law, Pharmacy Board guidelines can be used in disciplinary proceedings under the National Law or law of a co-regulatory jurisdiction as evidence of appropriate professional conduct or practice for pharmacists.

We also want to highlight Australia Post’s dangerous, prohibited and restricted items page which includes the Australia Post Prohibited and Restricted Item List and packaging guide (May 2022). This is a really useful resource which refers in the restricted item list to poison, drug or medicine that is not also a dangerous good, e.g. must not be toxic substances (i.e. regulated as dangerous goods).

Medicinal cannabis

The current regulatory landscape for medicinal cannabis is complex.

Ahpra recently provided guidance on medicinal cannabis prescribing. It builds on existing regulatory guidance about safe care, including each Board’s Code of conduct and their guidance on telehealth as well as virtual care.

Although that guidance is focussed on prescribing of medicinal cannabis, the Council remains concerned regarding Pharmacists dispensing medicinal cannabis in NSW and the potential risk to health and safety of the public.

The NSW Pharmacy quarterly stakeholder forum also developed NSW Medicinal Cannabis Guidance published in the October 2024 Council newsletter. This document lists a summary of requirements which all pharmacists working in this space should be familiar with. It collates many resources to ensure the supply of medicinal cannabis is in accordance with all legal and professional requirements.

Despite this Council has concerns regarding continued non-compliance. We have recently received several complaints about:

not complying with storage obligations for S8 medicines, including storage of drugs outside of a safe
not complying with recording obligations for S8 medicines, including not undertaking mandatory stock checks or making records of receipt, supply, administration or use of drugs of addiction on that date
supply without consideration to the quantity and purpose and whether it accords the recognised therapeutic standards of what is appropriate in the circumstances
not ensuring prescriptions comply with the legislative requirements, including prescriber’s details, quantity written in both words and figures, repeat intervals and supply outside the expiration of the script
not complying with prescriber’s directions, particularly in regard to repeat intervals and total monthly supply quantity of cannabis products
supply of medicinal cannabis on phone or fax orders where unregistered drugs of addiction are exempt from the emergency supply provisions
substitution of unregistered S8 cannabis medicines with another preparation of different brand, strain or strength without a valid new prescription.

Council would like to remind all pharmacists of their obligations to ensure they maintain compliance with the relevant NSW legislation, along with any published clinical guidance documents. The majority of complaints received by the Pharmacy Council relate to non-compliance with one or both of these documents.

We also wanted to remind pharmacists of their professional autonomy obligations, which involves balancing clinical judgment with the need to ensure patient safety and complying with regulations.

To help with this, pharmacists should consider use of tools available to support this role, including real time prescription monitoring (SafeScript). This will help guide you in assessing the appropriateness and risks for each patient, particularly with regard to medicinal cannabis and other monitored medications.

Proprietors need to make sure they have effective procedures around the identified areas of non-compliance listed above. It’s also critical to ensure adequate training, communication and oversight of their employees and pharmacies is in place.

Messages from NSW Health

You can now subscribe to pharmaceutical services new and updates

Pharmaceutical Services has recently launched a PSU subscription service for news, alerts, and updates. We'd appreciate your support in promoting this service to pharmacists, pharmacy students, through your networks. We plan to share information regularly, especially in the lead up to the implementation of the Medicine, Poisons and Therapeutic goods legislation early next year.

Updated UTI practice standard and class authority are now in force

NSW Health has published an updated practice standard and authority for the treatment of Urinary Tract Infections (UTI) under the extended scope of pharmacy practice. These updates align with the March 2025 edition of the Antibiotic Therapeutic Guidelines and reflect the latest recommendations for managing acute cystitis in non-pregnant adult females, including changes in antibiotic choice for first-line and subsequent treatment.

Pharmacists and pharmacies providing this service must meet the requirements of and adhere to this practice standard and authority. For further information see Treatment of UTIs – information for pharmacists.

Join the webinar – new guidelines for the management of UTIs

NSW Ministry of Health will be hosting a webinar for pharmacists on Thursday 14 August on the Management of UTIs under the pharmacy extended scope of practice.

You can also subscribe to hear about webinars and other Pharmaceutical Services news, updates and alerts.

The term "professional services room" updated to "medication storage and preparation room"

The Council has updated the relevant forms and guidance material on our website in response to new legislative amendments.

The Health Legislation Amendment (Miscellaneous) Bill 2025 (the Bill) made a minor, statute law revision change to the Health Practitioner Regulation (Adoption of National Law) Act updating the term professional services room to medication storage and preparation room to better reflect the purpose of these rooms.

The definition of medication storage and preparation room means premises in or on which a person carries on a pharmacy business that involves only:

(a) the preparation and packaging of drugs, or the packaging of drugs, by or under the personal supervision of a pharmacist, for supply to individual patients or to a health care facility for supply to patients or residents of that facility; and

(b) the storage of those drugs.

Please note that The Guide provides information about the regulatory framework within which the Council operates in respect of pharmacies and pharmacy ownership in NSW.